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Response Genetics Offers New Test for Lung Cancer Biomarker

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Response Genetics has launched testing for ROS1 gene rearrangements in lung cancer. Recently, the Massachusetts General Hospital Cancer Center published studies showing that ROS1 driven tumors are sensitive to the FDA approved drug Xalkori® (crizotinib) to treat non-small-cell lung cancer (NSCLC) patients with ALK gene rearrangements. Tumors driven by rearrangements in the ROS1 gene represent an additional 1–2% of patients who may be candidates for crizotinib therapy. The company will offer both FISH- and PCR-based ROS1 translocation testing.

"We believe the dual option of FISH and PCR represent a unique offering and is consistent with our Leave No Stone Unturned program whereby we go to great lengths to help patients receive optimal therapy," says Thomas Bologna, chairman and CEO of Response Genetics. "While FISH is the technology that has been used for ROS1 to date, PCR has the advantage of providing additional information about the variant found, information that may be useful for evaluating response and resistance mechanisms. This promising new marker is now readily available to pathologists and oncologists seeking fast turnaround time and utilizes the company's methods that enable results on very small biopsies including fine needle aspirates."

ROS1 supplements the firm's recently introduced Leave No Stone Unturned program, in which patients whose tumors test negative for the ALK Break Apart FISH assay receive follow-up ALK testing using the company's EML4-ALK RT-PCR-based assay. With the addition of ROS1, the firm says that ordering clinicians can now make a more complete evaluation of each of their NSCLC patients as candidates for crizotinib therapy.

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